This Study Coordinator has 15 years of experience in monitoring and management of Phase I-III clinical trials for various disease states, this Clinical Research Manager has worked for small and large Bio-Pharmaceutical companies. Comfortable working as a consultant or in-house, this manager can handle a wide variety of clinical projects.
- Organized and led project meetings and Kick-off meetings (create PPT presentations, and spoke/led the meetings)
- Interacted with cross-functional groups (Regulatory, Clinical Trial Material team, QA, etc.)
- Created and maintained timelines
- Negotiated budgets and contracts
- Supervised junior team members
- Compiled metrics and reported to management
- Protocol (and protocol amendment) development, CRF development and creation of other study tools (ICFs, monitoring plans, CRF and study guidelines), and reviewed/contributed to Investigator Brochures, Clinical Study Reports (patient narratives, etc.), and clinical section of INDs.
- Management of CROs and vendors
- Coordination of vendor selection process
- Site management, monitoring and oversight of regional monitors, and co-monitoring for training purposes
If you would like more information about this excellent candidate please contact us at: email@example.com.